FDA更新关于实施质量源于设计药业公司宣传文案资料.ppt

Considerations for QbD Applications End of Phase II is usually a good time to start discussions about QbD approaches Discuss how design space was developed Present a clear and comprehensive quality control strategy (including design space, in-process controls, specifications) Ensure quality system are capable to handle demands of QbD, PAT, and/or RTRT Continually monitor product and process to ensure quality ONDQA – Where do we go from here? ONDQA is accepting QbD applications outside of pilot program Early communication encouraged Continued work with ICH and international community Internal and external training Further refinement of QbD approaches for legacy products and for changes post-launch Concluding Comments Quality by Design has moved into the implementation phase ONDQA is putting the staffing and systems in place to support implementation of QbD New guidelines are in place or are being developed to help facilitate implementation Recent NDAs (both within and outside of the CMC pilot program) have provided opportunities for implementing QbD ONDQA encourages and accepts applications using QbD approaches Come in, we’re OPEN Acknowledgements Christine Moore Moheb Nasr Thank you! Questions, comments, concerns: NewDrugCMC@fda.hhs.gov FDA Update on Implementation of Quality by Design (QbD) FDA更新关于实施质量源于设计 Richard (Rik) Lostritto, Ph.D. Director, DPAMS Office of New Drug Quality Assessment CDER/FDA The New Jersey Pharmaceutical Association For Science and Technology新泽西州制药协会科学和技术 September 17, 2009 Outline大纲 FDA quality initiatives backgroundFDA 质量措施背景 QbD guidances QbD 指导 QbD activities and initiativesQbD 活动和建议 Remaining challenges and gaps挑战和差距 Concluding comments结论性意见 In 2002, FDA assessed the ongoing problems and issues in pharmaceutical manufacturing2002年，FDA评估药品生产的持续存在的问题 The final report issued in 2004, recommended:在2004年发行的最后报告，建议: Outreach and collaboration with industry Encourage risk-based pharmaceutical quality management systems for